Sirolimus and Auranofin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer or Small Cell Lung Cancer

NCT01737502 | Completed Phase 1 Results DMC FDA Drug

• 4 other identifiers: MC1125NCI-2012-0051811-001987R21CA153000
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

This phase I/II trial studies the side effects and best dose of auranofin when given together with sirolimus and to see how well it works in treating patients with lung cancer that has spread or other places in the body and cannot be cured or controlled by treatment or has come back after a period of time during which the cancer could not be detected. Auranofin and sirolimus may stop or slow the growth of lung cancer.

Conditions

Extensive Stage Small Cell Lung Carcinoma; Lung Adenocarcinoma; Recurrent Non-Small Cell Lung Carcinoma; Recurrent Small Cell Lung Carcinoma; Squamous Cell Lung Carcinoma; Stage IIIA Non-Small Cell Lung Cancer; Stage IIIB Non-Small Cell Lung Cancer; Stage IV Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Number of Phase 1 Patients Experiencing a DLT

  The number and severity of all adverse events (overall and by dose level) will be tabulated and summarized. A DLT is defined as an adverse event during the first cycle of, at least possibly related to study treatment, and one of the following: Grade 4 Neutropenia, Grade 4 Thrombocytopenia, ≥Grade 3 Anaphylaxis, ≥Grade 3 Proteinuria, ≥Grade 3 Hematuria, ≥Grade 3 Rash acneiform, ≥Grade 3 Diarrhea, ≥Grade 3 Mucositis oral

  28 days

• Number Phase 1 Patients Experiencing a Grade 3+ AE

  Number and severity of all adverse events (overall and by dose level) will be tabulated and summarized.

  Up to 5 years

• Progression-free Survival Rate

  A patient is considered to be a 4-month progression-free survivor, or success, if the patient is 4 months from registration without a documentation of disease progression. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the properties of the binomial distribution. Additionally, an estimate and confidence interval for the 4-month progression-free survival rate incorporating censoring may be computed using the method of Kaplan-Meier.

  4 months

Secondary Outcomes (4)

• Overall Survival Time

  up to 5 years

• Progression-free Survival Time

  up to 5 years

• Number of Patients Achieving a Complete Response (CR) or Partial Response (PR) Noted as the Objective Status

  Up to 5 years

• Duration of Response

  Up to 5 years

Other Outcomes (1)

• Change in Protein Kinase C (PKC) Iota Protein Expression

  Baseline to up to 5 years

Study Arms (1)

Treatment (auranofin and sirolimus)

EXPERIMENTAL

Patients receive auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Auranofin; Drug: Sirolimus; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study

Interventions

Auranofin DRUG

Given PO

Also known as: Ridaura

Treatment (auranofin and sirolimus)

Sirolimus DRUG

Given PO

Also known as: AY 22989, RAPA, SILA 9268A, WY-090217

Treatment (auranofin and sirolimus)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (auranofin and sirolimus)

Pharmacological Study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (auranofin and sirolimus)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic or cytologic confirmation of lung cancer (squamous, ras-mutated adenocarcinoma or small cell lung cancer)
• Patients must have received at least one course of chemotherapy consisting of a platinum doublet and must have no acceptable standard treatment options
• Prior radiation therapy is permitted as long as:
• Recovered from the toxic effects of radiation treatment before study entry, except for alopecia
• Absolute neutrophil count (ANC) \>= 1500 uL
• Platelets (PLT) \>= 100,000 uL
• Hemoglobin (Hgb) \>= 9 g/dL
• Total bilirubin =\< 1.5 x upper limit of normal (ULN) or direct bilirubin =\< ULN
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 3 x ULN or SGOT (AST) and SGPT (ALT) =\< 5 x ULN is acceptable if liver has tumor involvement
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2
• Negative serum pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
• Ability to provide informed consent
• Life expectancy \>= 12 weeks
• Willing to return to Mayo Clinic enrolling institution for follow-up
• Willing to provide tissue samples for correlative research purposes

You may not qualify if:

• Any of the following:
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception
• Symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases or seizure disorder; NOTE: patients with treated CNS metastases without evidence of progression and without uncontrolled symptoms or need for steroids may enroll
• Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded
• Unwilling or unable to, comply with the protocol
• Any of the following prior therapies:
• Radiation to \>= 25% of bone marrow
• Major surgery (i.e., laparotomy), open biopsy, or significant traumatic injury =\< 4 weeks prior to registration; minor surgery =\< 2 weeks prior to registration; insertion of a vascular access device is not considered major or minor surgery in this regard
• Any of the following concurrent severe and/or uncontrolled medical conditions:
• Hypertension, labile hypertension, or history of poor compliance with antihypertensive medication
• Angina pectoris
• History of congestive heart failure =\< 3 months, unless ejection fraction \> 40%
• Myocardial infarction =\< 6 months prior to registration

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Related Publications (2)

• Jatoi A, Foster NR, Wahner Hendrickson A, Block MS, Weroha SJ, Asmus EJ, Murray NR, Fields AP. A Phase 2 Trial of Protein Kinase C Iota Inhibition With the Combination of Auranofin and Sirolimus in Patients With Recurrent Ovarian Cancer. Am J Clin Oncol. 2025 Oct 20. doi: 10.1097/COC.0000000000001263. Online ahead of print.

  PMID: 41114938 DERIVED

• Rousselle B, Massot A, Privat M, Dondaine L, Trommenschlager A, Bouyer F, Bayardon J, Ghiringhelli F, Bettaieb A, Goze C, Paul C, Malacea-Kabbara R, Bodio E. Conception and Evaluation of Fluorescent Phosphine-Gold Complexes: From Synthesis to in vivo Investigations. ChemMedChem. 2022 Jun 3;17(11):e202100773. doi: 10.1002/cmdc.202100773. Epub 2022 Mar 29.

  PMID: 35254001 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Adenocarcinoma of Lung; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Auranofin; Sirolimus

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Aurothioglucose; Organogold Compounds; Organometallic Compounds; Organic Chemicals; Macrolides; Lactones

Results Point of Contact

• Title: Yanyan Lou, MD
• Organization: Mayo Clinic in Florida

lou.yanyan@mayo.edu

904-953-0315

Study Officials

• Yanyan Lou, M.D., Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: November 29, 2012
• Study Start: May 14, 2014
• Primary Completion: April 24, 2023
• Study Completion: April 24, 2023
• Last Updated: September 5, 2025
• Results First Posted: August 20, 2025

Record last verified: 2024-03

Locations

US (2)